Abbott Glucose Test Can Give False Positive Warns Health Canada

Abbott Glucose Test Can Give False Positive

Toronto, Ontario – As diabetics well know, managing blood sugar levels tends to be more art than science as illness, work stress, weather, and a myriad of factors beyond a person’s control can cause blood sugar levels to change. According to the sugar levels, a person has to adjust their diet and use of insulin to avoid have either too low of a blood sugar level (hypoglycemia) or too high of a blood sugar level (hyperglycemia). Each condition carries with it health risks.

Now, diabetics in Canada have been alerted that Abbott FreeStyle glucose test strips have been shown to give incorrect low blood sugar readings. Specifically, the test strips can report a blood sugar level that is worse than it is in reality. This may lead a person to inject too much insulin or otherwise “over correct” the low blood sugar inducing hyperglycemia in themselves. The test strips in the health warning are:

Abbott Diabetes Care’s FreeStyle Blood Glucose Meter
Abbott Diabetes Care’s FreeStyle Mini Blood Glucose Meter
Insulet’s OmniPod Insulin Management System

Diabetics using those strips are advised to contact either their health care provider or Abbott Diabetes Care to address their questions and concerns. It has not been a good year for Abbott with two prior models already having been recalled just last month. Those products were the FreeStyle Blood Glucose and the FreeStyle Flash Monitoring systems. Abbott also had three other blood sugar monitoring products recalled in 2012. Health Canada issued the recent warning.

Here is the official press release from Health Canada:

Issue

Health Canada is informing Canadians that when Abbott FreeStyle glucose test strips are used with the devices listed below, there is a potential for users to receive a lower-than-actual blood sugar reading.

False low blood sugar readings may lead to improper treatment decisions for users, such as increasing the consumption of sugar or not taking enough insulin, which in turn could lead to hyperglycemia (elevated blood sugar levels).

The three devices are: Abbott Diabetes Care’s FreeStyle Blood Glucose Meter and FreeStyle Mini Blood Glucose Meter, and Insulet’s OmniPod Insulin Management System.

Consumers with the affected FreeStyle meters should contact Abbott Diabetes Care at 1-877-576-9368.

Consumers with the Insulet OmniPod Insulin Management System should contact Abbott Diabetes Care at 1-877-607-6364 regarding the Freestyle strips, or if they have questions about the use of the system they should contact Insulet at 1-855-763-4636.

The two companies are notifying customers to inform them of this issue.

Consumers who have concerns related to the use of these devices should speak with their health care professional.

Report health or safety concerns

Complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

Source:

Health Canada warns about faulty glucose strips